Melissa Schulz
St. Louis,MO
Summary
Quality Assurance and Reliability leader with 12+ years of experience across regulated healthcare, pharmaceutical, clinical, and IT environments. Proven expertise in incident and outage management, change governance, SOP lifecycle management, audit readiness, and regulatory compliance, aligned with ITIL, FDA, ISO, and CLIA standards. Recognized for driving operational resilience, reducing risk, and maintaining inspection-ready systems while partnering cross-functionality with IT, Operations, Security, and Quality teams
Overview
15
15
years of professional experience
2
2
Certification
Work History
Reliability Manager
United BioSource Corporation
2022 - Current
- Lead enterprise reliability and governance for a regulated healthcare environment, overseeing IT incident and outage management, change control, and SOP lifecycle governance
- Partner closely with IT, IT Security, and Operations teams to minimize business impact, improve Mean Time to Resolution (MTTR), and ensure audit ready systems
- Chair the Change Advisory Board (CAB), applying risk-based decision making to production changes while tracking incidents, root cause analysis (RCAs), corrective and preventative actions (CAPAs), and change outcomes to identify systemic risks and improvement opportunities
Document Control Specialist Contractor
C2N Diagnostics
2021 - 2022
- Supported quality system governance through end-to-end document control and records management within a regulated diagnostic environment
- Managed Document Change Requests (DCRs), Quality System event databases, and Master Document Lists while administering the Electronic Document Management Systems (EDMs)
- Ensured controlled documentation integrity, archival, and retention, and supported client and regulatory audits through preparation, reconciliation, and follow-up activities
Clinical Quality Assurance Specialist
Pfizer
2020 - 2021
- Provided quality oversight within a clinical and pharmaceutical setting, reviewing investigations, deviations, CAPAs, and change controls using a risk-based approach
- Drove process improvements to strengthen compliance and operational efficiency while collaborating cross-functionality with Quality Control, Engineering, and Technical Services
- Facilitated regular quality discussions with department leadership to address trends, risks, and continuous improvement opportunities
Quality Assurance Manager
Octapharma Plasma Center
2015 - 2020
- Led Quality Assurance operations and cGMP-regulated environment, maintaining compliance with SOPs and regulatory requirements while ensuring inspection-ready operations
- Directed regulatory, customer, and internal audits, owning responses, CAPA execution, and timely closure
- Analyzed quality metrics and KPIs to identify trends, reduce risk, and drive continuous improvement initiatives, including elimination of non-value activities and redundant documentation
Education
Associate of Science -
Allied College
MOSkills
- Incident & Outage Management
- Change Management (CAB)
- SOP Lifecycle Governance
- Root Cause Analysis (RCAs)
- Corrective and Preventative Actions (CAPAs)
- Risk Management
- Audit Readiness & Inspection Support
- ITIL Aligned Processes
- Quality Management Systems (QMS)
- Collaborative team management
- Effective time management
Certification
- BSI Certificate of Competency - Medical Device Quality Management Systems (ISO 13485:2016)
- BSI Certificate of Competency - Management System Auditing (ISO 19011:2018)
Regulatory & Standards Experience
- FDA (21 CFR Part 820/11)
- cGMP
- CLIA
- ISO 9000
- ISO 13485:2016
- ISO 19011:2018
Timeline
Associate of Science -
Allied College
Reliability Manager
United BioSource Corporation
2022 - Current
Document Control Specialist Contractor
C2N Diagnostics
2021 - 2022
Clinical Quality Assurance Specialist
Pfizer
2020 - 2021
Quality Assurance Manager
Octapharma Plasma Center
2015 - 2020